Methods and machines for making oral products

ABSTRACT

A method of forming an oral product includes extruding a mixture, conveying the extruded mixture through one or more pairs of forming rollers, and cutting the extruded mixture into one or more oral products. The mixture can include polymer and at least one flavorant, sweetener, active ingredient, or combination thereof. The extruded mixture forms an extrudate having a predetermined cross-sectional shape. The one or more pairs of forming rollers abut to define a passage there between as each forming roller rotates. The passage has a cross-sectional shape corresponding to the predetermined cross-sectional shape. The method can be performed using a machine including an extruder, one or more pairs of forming rollers, and a cutting device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 14/206,688, filed Mar. 12, 2014; which claims the benefit ofpriority under 35 U.S.C. § 119(e) to U.S. Application No. 61/786,326filed Mar. 15, 2013, the entire contents of each of which are herebyincorporated by reference.

TECHNICAL FIELD

This document relates to methods and machines for cutting extrudedmaterial into individual pieces.

BACKGROUND

Oral products providing flavor and/or one or more active ingredients arewell known. One such oral product is chewing gum (e.g., nicotine gum).Other oral products include hard candies (e.g., mints). Softergelatin-based oral products are also known. Pharmaceutical andtherapeutic products (e.g., cough-suppressant lozenges) can also beprovided in a solid form for oral consumption. Smokeless tobaccoproducts can also be provided in a number of different forms. The flavorrelease and/or active agent release characteristics for an oral productare important for providing an improved consumer product.

SUMMARY

This specification provides methods and machines for extruding a mixtureof a polymer and one or more flavorants, sweeteners, and/or actives toform an extrudate having a predetermined cross-section, passing theextrudate through at least one pair of forming rollers, and cuttingmaterial from the extrudate to form a plurality of oral products. Insome cases, the oral product can provide an extended additive releasetime. The oral product includes a body that is at least partiallyreceivable in an oral cavity of a consumer. In some cases, the oralproduct includes a mouth-stable polymer matrix, cellulosic fibersembedded in the stable polymer matrix, and one or more additivesdispersed in the body such that it is released when the body is receivedwithin the oral cavity and exposed to saliva.

A machine provided herein for cutting an extrudate can include aplurality of forming rollers that pair and abut to form a passagetherebetween. The passage can have a predetermined cross-sectionalshape. In some cases, the passage can have a shape corresponding to thecross-sectional shape of the extrusion die. In some cases, passage of afirst pair of forming rollers has a passage that is larger than thecross-sectional shape of the extrusion die, which can account for anexpansion of the extrudate as it leaves the extrusion die. In somecases, a first pair of forming rollers can have the same cross-sectionalshape and same dimensions as that of the extrusion die, which cancorrect for any deformation and/or expansion of the extrudate betweenthe extrusion die and the first pair of forming rollers. In some cases,a plurality of pairs of forming rollers each has a passage therebetweenhaving the same cross-sectional shape and same dimensions. In somecases, a plurality of pairs of forming rollers can get progressivelysmaller as a function of distance from an extrusion die. The formingrollers can be driven by a drive motor. In some cases, a gear train canbe used with the drive motor to rotate each roller at the same speed.The drive motor and gear train can maintain a rotation of each formingroller at a speed consistent with the speed of the extrudate as it exitsthe extrusion die. The forming rollers can transport the soft extrudatefrom the extrude die to a cutting section while maintaining a desireduniform cross-sectional shape of the extrudate or reshaping theextrudate to have a uniform cross-sectional shape. The forming rollerscan also allow the soft extrudate to cool and become more rigid prior tothe cutting section, which can prevent a cutting operation fromdeforming the cross-sectional shape of the oral products as they are cutfrom the extrudate. In some cases, the machine provided herein caninclude one or more holding rollers positioned between an extrusion dieand a first pair of forming rollers.

A cutting section of the machine provided herein can include a cuttingledger to support the extrudate as it is cut. In some cases, the cuttingledger includes channels there through to allow for the passage of aheat exchange fluid (e.g., cooled water) there through in order tocontrol a temperature of the cutting ledger. The cutting section of themachine provided herein can include a cutting blade. The cutting bladecan be a rotary cutting blade operated by a motor. In some cases, therotary cutting blade can be rotated at a continuous speed. In somecases, the rotary cutting blade can be intermittent. Intermittent motionof the blade can be controlled on a time basis or can be controlled by asensor that detects the position of the extrudate. For example, a sensorcan detect a leading edge of the extrudate and a signal form the sensorcan be used to actuate a rotary motion of the cutting blade, which canallow for uniform oral products to be cut form the extrudate regardlessof the rate at which the extrudate is being fed into the cuttingsection. A programmable logic controller can be used to sequence andcontrol the various operations, such as the speed of the extrudate as itexits the extrusion die, the speed of rotation of the forming rollers,and the speed or actuation of the cutting blade.

The passages of the forming rollers and/or the extrusion die can have avariety of different shapes. In some cases, the passages of the formingrollers and/or the extrusion die can be circular, shield-shaped, orrectangular. In some cases, the passages of the forming rollers and/orthe extrusion die can have a maximum diameter and a minimum diameter ofbetween 5 mm and 25 mm.

A method provided herein can include passing the extrudate as it exitsan extruder through a plurality of pairs of forming rollers such thatthe section of the extrudate passing through a final pair of formingrollers has a temperature of less than 10 degrees Celsius below theglass transition temperature of a polymer material forming a matrix ofthe extrudate. In some cases, the forming rollers can impart a desiredsurface texture to the extrudate. A method provided herein can includemaintaining a uniform cross-sectional shape of the extrudate as itpasses through the plurality of the pairs of forming rollers. A methodprovided herein can include further cooling the extrudate in a cuttingledger after the extrudate passes through a final pair of formingrollers prior to cutting the extrudate. A method provided herein caninclude cutting the extrudate with a cutting blade that is actuated by asensor that detects a position of a leading edge of the extrudate. Insome cases, the cutting blade can be timed or actuated to produce oralproducts having a thickness of between 1 mm and 10 mm.

The oral product can include flavorants, sweeteners, vitamins, minerals,therapeutic agents, nutraceuticals, energizing agents, soothing agents,coloring agents, amino acids, chemesthetic agents, antioxidants, foodgrade emulsifiers, pH modifiers, botanicals, teeth whitening agents,and/or alkaloids (e.g., nicotine, caffeine). Combinations of additives(e.g., sweeteners, flavorants, and caffeine) can be combined to providea favorable tactile and flavor experience. The oral product, in somecases, includes nicotine or a derivative thereof. The oral product canprovide a tobacco-like flavor experience and favorable tactileexperience. Combinations of additives (e.g., sweeteners, flavorants, andnicotine) can be combined to provide a favorable tactile and flavorexperience.

In some cases, the oral product can include tobacco plant tissue. Inother cases, the oral product is substantially free of tobacco planttissue. Nicotine can be included in an oral product that issubstantially free of tobacco plant tissue. Nicotine included in an oralproduct can be either synthetic or derived from tobacco. In some cases,the oral product includes between 0.1 mg and 6 mg nicotine. The oralproducts can also include an additive selected from the group consistingof minerals, vitamins, dietary supplements, nutraceuticals, energizingagents, soothing agents, amino acids, chemesthic agents, antioxidants,botanicals, teeth whitening agents, therapeutic agents, or a combinationthereof. The nicotine and/or other additives can be absorbed into thecellulosic fibers and polymer matrix.

The oral product body can have at least 10 weight percent cellulosicfibers. The cellulosic fibers can be derived from plant tissue. In somecases, the cellulosic fibers include cellulose. The cellulosic fiberscan further include lignin and/or lipids. In some cases, the cellulosicfibers can include tobacco plant tissue (e.g., exhausted tobacco plantfibers). The cellulosic fibers can be non-tobacco cellulosic fibers. Forexample, the cellulosic fibers can be selected from the following: sugarbeet fiber, wood pulp fiber, cotton fiber, bran fiber, citrus pulpfiber, grass fiber, willow fiber, poplar fiber, and combinationsthereof. The cellulosic fibers may also be chemically treated prior touse. For example, the cellulosic fibers can be CMC, HPMC, HPC, or othertreated cellulosic material.

The oral product can include flavorants. The flavorants can be naturalor artificial. Flavorants can be selected from the following: licorice,wintergreen, cherry and berry type flavorants, Drambuie, bourbon,scotch, whiskey, spearmint, peppermint, lavender, cinnamon, cardamom,apium graveolents, clove, cascarilla, nutmeg, sandalwood, bergamot,geranium, honey essence, rose oil, vanilla, lemon oil, orange oil,Japanese mint, cassia, caraway, cognac, jasmine, chamomile, menthol,ylang-ylang, sage, fennel, piment, ginger, anise, coriander, coffee,mint oils from a species of the genus Mentha, cocoa, and combinationsthereof. Synthetic flavorants can also be used. In some cases, acombination of flavorants can be combined to imitate a tobacco flavor.The particular combination of flavorants can be selected from theflavorants that are generally recognized as safe (“GRAS”). Flavorantscan also be included in the oral product as encapsulated flavorants.

The oral product can also include a sweetener dispersed in the body. Thesweetener can be saccharine, sucralose, aspartame, acesulfame potassium,or a combination thereof.

The oral product body can include at least 10 weight percent of themouth-stable polymer. The mouth-stable polymer matrix can includepolyurethane, silicon polymer, polyester, polyacrylate, polyethylene,poly(styrene-ethylene-butylene-styrene) (“SEBS”),poly(styrene-butadiene-styrene) (“SBS”),poly(styrene-isoprene-styrene)(“SIS”), and other similar thermoplasticelastomers, or any copolymer, mixture, or combination thereof. The oralproduct can also include a plasticizer dispersed in the mouth-stablepolymer matrix. For example, the plasticizer can be propylene glycol,glycerin, vegetable oil, triglycerides, or a combination thereof.

The body of the oral product can have a variety of different shapes,some of which include disk, shield, rectangle, and square. According tocertain embodiments, the body can have a length or width of between 5 mmand 25 mm and a thickness of between 1 mm and 10 mm.

The oral product body can be compressible and springy. In some cases,the body has a compressibility @ 250 N of less than 95%, less than 90%,less than 85%, or less than 80%. In some cases, the body has acompressibility of @ 250 N of between 45% and 90%. The body can have acompressibility @ 425 N of less than 99%. For example, the body can havea compressibility @ 425 N of between 60% and 98%. The body can also havea percentage of springiness of at least 20%, at least 30%, at least 40%,at least 50%, at least 60%, at least 70%, or at least 75%. For example,the body can have a percentage of springiness of between 75% and 90%.

The oral product can also include an antioxidant. In some cases, theoral product includes between 0.01 weight percent and 5.0 weight percentantioxidant. Suitable antioxidants include ascorbyl palmitate, BHT,ascorbic acid, sodium ascorbate, monosterol citrate, tocopherols, propylgallate, tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole(BHA), Vitamin E, and derivatives thereof. The combination ofantioxidant and nicotine can reduce the formation of nicotine-N-oxide.

The oral product can include a combination of soluble fibers andinsoluble cellulosic fibers. In some cases, a ratio of soluble fiber tocellulosic fibers can be between 1:60 and 60:1. In some cases, thesoluble fibers can include maltodextrin. In some cases, the solublefibers comprise starch. The soluble fibers can be derived from corn. Ingeneral, another aspect of the subject matter described in thisspecification is methods of making and using the oral product. Themethods of making the oral product can include the actions of extrudinga mouth-stable polymer having cellulosic fibers and/or one or moreadditives dispersed therein.

The details of one or more embodiments of the subject matter describedin this specification are set forth in the accompanying drawings and thedescription below. Other features, aspects, and advantages of thesubject matter will become apparent from the description, the drawings,and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a machine used to shape and cut oralproducts.

FIG. 1B is an expanded view of the machine of FIG. 1A.

FIGS. 2A-2C depict a forming roller section of the machine of FIG. 1A.

FIG. 3 is a perspective view of a cutting section of the machine of FIG.1A.

FIG. 4 is a perspective view of a pair of oral products.

FIGS. 5A-5L illustrate various exemplary shapes of oral products.

DETAILED DESCRIPTION

Machines and methods for forming oral products are provided herein. Theoral products can include a mouth-stable polymer matrix and one or moreadditives. The additives can include flavorants, sweeteners, activeingredients, or any other suitable ingredient intended to be releasedfrom the oral product when the oral product is received within the oralcavity and exposed to saliva. The oral products can provide a favorableadditive release profile and tactile experience. The methods andmachines provided herein can produce oral products have uniformdimensions. In some cases, the oral products can have smooth surfaces.In some cases, the oral products can have textured surfaces. The methodsand machines provided herein can produce oral products that provide anextended and controlled release of additives within the polymer matrix.

Cutting an extrudate as it exits an extrusion die is a typical way tomake pellets of extruded material. Cutting an extrudate intended for useas an oral product, however, can result in a deformation of the materialsuch that it does not have the desired dimensions. This can occur due tothe different velocities of the extruded material as a function ofdistance from the extrusion die wall. In particular, the extrudedmaterial along the extrusion die wall can have a lower velocity thanmaterial in the middle of the extrudate. Attempts to cut the material atthe extrusion die can thus result in the formation of a dome after thecut is made, rather than a flat face. Additionally, the differences invelocity can result in an uneven surface texture. Moreover, thedeformation of the material can result in sharp edges that can providean unpleasant mouth feel. The machines and methods provided herein,however, allow for oral products having desired dimensions to bereliably produced. The oral products can have flat cut faces. The oralproducts can have consistent and desired surface properties. The oralproducts can have uniform cross-sectional shapes and/or uniformthicknesses. Uniform dimensions, and thus uniform weights, can alsoprovide products that consistently provide predetermined amounts of oneor more additives and/or consistent release properties.

The machine provided herein includes or couples to an extruder andprovides a positive transfer of the extrudate from the extrusion die toa cutting section of the machine. The machine further maintains and/orreshapes the cross-sectional shape of the extrudate as it solidifies toprovide a uniform cross-sectional shape of the extrudate as it reachesthe cutting section. The cutting section can provide a clean cut to theextrudate to provide a plurality of oral products have uniformdimensions.

FIGS. 1A and 1B depict an exemplary machine 100 used to produce oralproducts. As shown, the machine can be positioned adjacent to anextruder E such that an extrudate exiting an extrusion die 110 isreceived by a holding section 120 including a plurality of holdingrollers 122. Adjacent to the holding section 120 is a forming section130 including a plurality of pairs of forming rollers. The plurality ofpairs of forming rollers can be driven by a drive motor 132 and a geartrain 134. Adjacent to the forming section 130 is a cutting section 150,where the extrudate can be cut into a plurality of oral products. Themachine 100 can include a cover 140 that sits over the forming section130 and the cutting section 150. The cover 140 can be retractable sothat an extrudate can be threaded through the forming rollers and intothe cutting section 150 during start up or repair. In some cases, themachine 100 includes an actuator system to open up the forming rollersto facilitate the threading of the extrudate through the machine 100during start up or repair.

Holding section 120 is optional. In some case, the extrusion die 110 canbe positioned so that the extrudate leaving the extrusion die 110immediately passes into a first pair of forming rollers. The holdingrollers 122 of holding section 120 can support the extrudate as it exitsthe extrusion die 110 and is pushed/pulled to the forming section 130.In some cases, the holding rollers 122 can spin freely so that they movewith the movement of the extrudate. In some cases, the holding rollers122 can be driven so that they provide positive transport of theextrudate from the extrusion die 110 to the forming section 130. Thedriven speed of the holding rollers 122 can be such that the surfacespeed of the holding rollers 122 is substantially equivalent to thelinear speed at which the extrudate exits the extrusion die 110 and thusthe cross sectional area of the extrudate is not significantly changedbetween the extrusion die 110 and the forming section 130. The drivenspeed of the holding rollers 122 can be such that the surface speed ofthe holding rollers 122 is greater than the linear speed at which theextrudate exits the extrusion die 110 and thus the cross sectional areaof the extrudate is reduced between the extrusion die 110 and theforming section 130. The driven speed of the holding rollers 122 canalso be such that the surface speed of the holding rollers 122 is lessthan the speed at which the extrudate exits the extrusion die 110 andthus the cross sectional area of the extrudate is increased between theextrusion die 110 and the forming section 130. An outer surface of eachholding roller 122 can include a groove for receiving the extrudate sothat the extrudate does not fall off of the holding rollers 122. In somecases, the groove can generally correspond to a portion of across-sectional shape of the extrudate.

FIGS. 2A-2C depict different views of forming section 130. The formingsection 130 includes at least one pair of forming rollers. In somecases, the forming section includes at least two pairs of formingrollers, at least three pairs of forming rollers, or at least four pairsof forming rollers. The machine depicted in FIGS. 1A, 1B, and 2A-2Cincludes four pairs of forming rollers 210, 212, 220, 222, 230, 232,240, and 242. Each forming roller includes a groove 211, 213, 221, 223,231, 233, 241, and 243 along an outer surface of the forming roller.Each pair of forming rollers abuts such that a passage there between isformed. As shown in FIG. 2C a passage 215 is formed between formingrollers 210 and 212. The passages can maintain a constantcross-sectional shape as each forming roller rotates. Thecross-sectional shape of passage (e.g., 215) between the pairs offorming rollers can correspond to the shape of the extrudate and/or tothe cross-sectional shape of the extrusion die 110. In some cases, thepassages between forming rollers can have a total cross-sectional areathat is within 25% of the cross-sectional area of the extrudate enteringthe forming section 130 or the cross-sectional area of extrusion die110. In some cases, the passage between each pair has the samecross-sectional shape and the same dimensions. In some cases, eachsuccessive passage can have slightly different dimensions. In somecases, each successive passage is reduced in cross-sectional area bybetween 0.1% and 10%. In some cases, each successive passage is reducedin cross-sectional area by between 0.5% and 5%. For example, eachsuccessive passage can be reduced by about 1%, about 3%, or about 5% incross-sectional area.

The forming rollers can each be driven by one or more motors. Forexample, as shown in FIGS. 1A, 1B, and 2A-2C, a single drive motor 132can drive the forming rollers using a gear train 134. The gear train 134can cause each pair of forming rollers to rotate at the same speed. Insome cases, independent motors can be used for each pair of formingrollers or each forming roller. In some cases, the gear train 134 orindependent motors can be used to cause each pair of forming rollers torotate at a different speed. These variations in speed, combined withvariations in the cross sectional shape and dimensions of the passages(e.g., 215) between the pairs of forming rollers can be used to changethe cross sectional shape and dimensions of the extrudate. The rotationof the forming rollers can provide a positive transfer of the extrudateto the cutting section. The forming rollers can be controlled (e.g., bya programmable logic controller 160) to rotate such that the outerlinear speed of each forming roller is approximately equal to the linearspeed at which the extrudate exits the extrusion die 110. The positivetransfer can allow for the extrudate to maintain a uniformcross-sectional shape and for any surface defects to be reshaped whilethe extrudate is solidifying such that the relative velocities of thematerial in the extrudate move at the same velocities. The driven speedof the forming rollers (e.g., 210 and 212) can be such that the surfacespeed of the forming rollers (e.g., 210 and 212) is substantiallyequivalent to the linear speed at which the extrudate exits theextrusion die 110 or the holding rollers 122 and thus the crosssectional area of the extrudate is not significantly changed between theextrusion die 110 or the holding rollers 122 and the cutting section150. The driven speed of the forming rollers (e.g., 210 and 212) can besuch that the surface speed of forming rollers (e.g., 210 and 212) isgreater than the linear speed at which the extrudate exits the extrusiondie 110 or the holding rollers 122 and thus the cross sectional area ofthe extrudate is reduced between the extrusion die 110 or the holdingrollers 122 and the cutting section 150. The driven speed of the formingrollers (e.g., 210 and 212) can also be such that the surface speed ofthe forming rollers (e.g., 210 and 212) is less than the speed at whichthe extrudate exits the extrusion die 110 or the holding rollers 122 andthus the cross sectional area of the extrudate is increased between theextrusion die 110 or the holding rollers 122 and the cutting section150.

The passages (e.g., 215) between the forming rollers can maintain theextrudates constant cross-sectional shape and/or reshape the extrudate.As shown, passage 215 has a shield shape, which can be used to create anoral product 410L such as that shown in FIG. 5L. In some case, thepassages can have other shapes, such as shapes the correspond to theshapes of the products depicted in FIGS. 4 and 5A-5L, which arediscussed below.

The cutting section 150 receives the extrudate from the forming section130. FIG. 3 depicts an exemplary cutting section 150, that includes acutting ledger 310 adapted to support the extrudate as it is cut and acutting device 320 having a cutting blade 324. The cutting ledger 310can included a grooved surface adapted to receive the extrudate. Thecutting blade 324 can form a shearing abutment with the cutting ledger310 in order to facilitate a clean cut. The cutting ledger 310 can beadapted to further cool the extrudate. For example, the cutting ledger310 can include channels there through for receiving a cooling fluid(e.g., cooling water) from a supply line 314. The cooling fluid can exitthe cutting ledger 310 through exit line 316. In some cases, thecombination of the different rollers and/or the cutting ledger 310 cancool the extrudate to a temperature of at least 1° C. less than theglass transition temperature of the polymer forming the matrix of theextrudate. In some cases, the combination of the different rollersand/or the cutting ledger 310 can cool the extrudate to a temperature ofat least 5° C. less than the glass transition temperature of the polymerforming the matrix of the extrudate. In some cases, the combination ofthe different rollers and/or the cutting ledger 310 can cool theextrudate to a temperature of at least 10° C. less than the glasstransition temperature of the polymer forming the matrix of theextrudate.

The cutting blade 324 can be actuated by a drive motor 322. In somecases, the cutting blade can operate with a continuous rotary motiontimed based on the extrusion speed and/or the forming roller speeds. Insome case, the cutting blade 324 can be intermittently rotated. Theintermittent motion of a cutting blade 324 can be time controlled basedon the extrusion speed and/or the forming roller speeds. In some cases,intermittent motion of a cutting blade 324 can be controlled (e.g., aprogrammable logic controller 160) based on a sensor 330 detecting aposition of the extrudate. For example, a sensor 330 can detect aleading edge of the extrudate and actuate the cutting device 320 oncethe leading edge of the extrudate is a certain distance past the leadingedge of the cutting ledger 310. In some cases, the sensor 330 can be alaser sensor. In some cases, a programmable logic controller can controlthe motion of the cutting blade 324 based on the sensor 330, informationabout the extrusion speed, and/or information about the forming rollerspeeds.

A programmable logic controller 160 can be part of the machine 100 tosequence and/or control the various operations. In some cases, theprogrammable logic controller 160 can be a computer coupled to themachine 100.

Oral Product Shapes and Packaging

FIG. 4 depicts an example of an oral product 410. The oral product 410has a disk shape. For example, the oral product 410 can have a diameterof about 12 mm and a thickness of about 2.5 mm. The oral products can bemolded into any other desired shape. For example, referring to FIGS.5A-5L, the oral product 410A-L can be formed in a shape that promotesimproved oral positioning in the oral cavity, improved packagingcharacteristics, or both. In some circumstances, the oral product 410A-Lcan be configured to be: (A) an elliptical-shaped oral product 410A ;(B) an elongated elliptical-shaped oral product 410B; (C) semi-circularoral product 410C; (D) square or rectangular-shaped oral product 410D;(E) football-shaped oral product 410E; (F) elongated rectangular-shapedoral product 410F; (G) boomerang-shaped oral product 410G; (H)rounded-edge rectangular-shaped oral product 410H; (I) teardrop- orcomma-shaped oral product 410I; (J) bowtie-shaped oral product 410J; (K)peanut-shaped oral product 410K; and (L) shield-shaped oral product410L.

One or more oral products 410 or 410A-L can be packaged in a variety ofconventional and non-conventional manners. For example, a plurality oforal products 410 or 410A-L can be packaged in a container having a lid.In some cases, a plurality of oral products 410 or 410A-L can be stackedand packaged in a paper, plastic, and/or aluminum foil tube. Thepackaging can have a child-resistant lid. The oral product 410 or 410A-Lcan also include additional elements. In some cases, a mouth-stablepolymer matrix including nicotine or a derivative thereof can beattached to a rod, tube, or stick.

Other Materials

The extrudate and thus the resulting oral products 410 or 410A-L includeat least one polymer and one or more additives. The additives can beflavorants, sweeteners, active ingredients, or any other substanceintended to be released when placed within a mouth. The ingredientslisted below are merely illustrative and non-limiting.

Polymers

In some cases, the polymer can be a mouth-stable polymer. Suitablemouth-stable polymers include thermoplastic elastomers such aspolyurethane. As used here, the term “mouth stable” means that thepolymer does not appreciably dissolve or disintegrate when exposed tosaliva within an oral cavity and at the normal human body temperature(e.g., about 98.6° F.) over a period of one hour. In addition tobiostable polymers, mouth-stable polymers can include biodegradablepolymers that breakdown over periods of days, weeks, months, and/oryears, but do not appreciably break down when held in an oral cavity andexposed to saliva for a period of one hour. In some cases, themouth-stable polymer is stable within an oral cavity and exposed tosaliva at the normal human body temperature for a period of at least 6hours, at least 12 hours, at least 24 hours, or at least 2 days.Accordingly, the oral products described herein can remain intact whenplaced within an oral cavity during a use period. After use, themouth-stable polymer matrix can be removed from the oral cavity anddiscarded.

The mouth-stable polymer can be a variety of different biocompatible andbiostable polymers. In some cases, the mouth-stable polymer is a polymergenerally recognized as safe by an appropriate regulatory agency. Insome cases, the polymer is a thermoplastic polymer. The polymer can alsobe a thermoplastic elastomer. For example, suitable mouth-stablepolymers include polyurethanes, silicon polymers, polyesters,polyacrylates, polyethylenes, polypropylenes, polyetheramides,polystyrenes (e.g., acrylonitrile butadiene styrene, high impactpolystyrenes (HIPS)) polyvinyl alcohols, polyvinyl acetates, polyvinylchlorides, polybutyl acetates, butyl rubbers (e.g., polyisobutylenes),SEBS, SBS, SIS, and mixtures and copolymers thereof. In some cases, themouth-stable polymer is food-grade or medical-grade polymers (e.g.,medical-grade polyurethane).

The mouth-stable polymer forms the mouth-stable polymer matrix of theextrudate and the resulting oral products 410 or 410A-L. In some cases,the extrudate includes at least 10 weight percent of one or moremouth-stable polymers. In some cases, the extrudate includes at least 20weight percent, at least 30 weight percent, at least 40 weight percent,at least 50 weight percent, at least 60 weight percent, at least 70weight percent, at least 80 weight percent, or at least 90 weightpercent of one or more mouth-stable polymers. In some cases, theextrudate includes between 10 and 90 weight percent of one or moremouth-stable polymers. Accordingly to some embodiments, the extrudateincludes between 40 and 80 weight percent of the mouth-stable polymers.

The mouth-stable polymer according to certain embodiments has a flexuralmodulus of at least 5 MPa when tested according to ASTM Testing MethodD790 or ISO 178 at 23 degrees Celsius. In some cases, the flexuralmodulus is at least 10 MPa. For example, the flexural modulus can bebetween 10 MPa and 30 MPa. In some cases, the mouth-stable polymer is agrade that complies with food-contact regulations applicable in one ormore countries (e.g., US FDA regulations). In some cases, themouth-stable polymer can be a polyurethane, SIS, or other thermalplastic elastomer meeting the requirements of the FDA-modified ISO10993, Part 1 “Biological Evaluation of Medical Devices” tests withhuman tissue contact time of 30 days or less. The mouth-stable polymercan have a shore Hardness of 50 D or softer, a melt flow index of 3 g/10min at 200° C./10 kg, a tensile strength of 10 MPa or more (using ISO37), and a ultimate elongation of less than 100% (using ISO 37).

Additives

A variety of additives can be included in the extrudate. The additivescan include alkaloids (e.g., caffeine, nicotine), minerals, vitamins,dietary supplements, nutraceuticals, energizing agents, soothing agents,coloring agents, amino acids, chemesthetic agent, antioxidants, foodgrade emulsifiers, pH modifiers, botanicals (e.g., green tea), teethwhitening (e.g., SHRIMP), therapeutic agents, sweeteners, flavorants,and combinations thereof. In some cases, the additives include nicotine,sweeteners, and flavorants. In some cases, the nicotine can be tobaccoderived nicotine. With certain combinations of nicotine, sweeteners, andflavorants, the oral product may provide a flavor profile and tactileexperience similar to certain tobacco products.

The extrudate can also include one or more antioxidants. Antioxidantscan result in a significant reduction in the conversion of nicotine intonicotine-N-oxide when compared to oral products without antioxidants. Insome cases, the extrudate can include 0.01 and 5.00 weight percentantioxidant, between 0.05 and 1.0 weight percent antioxidant, between0.10 and 0.75 weight percent antioxidant, or between 0.15 and 0.5 weightpercent antioxidant. Suitable examples of antioxidants include ascorbylpalmitate (a vitamin C ester), BHT, ascorbic acid (Vitamin C), andsodium ascorbate (Vitamin C salt). In some cases, monosterol citrate,tocopherols, propyl gallate, tertiary butylhydroquinone (TBHQ),butylated hydroxyanisole (BHA), Vitamin E, or a derivative thereof canbe used as the antioxidant. For example, ascorbyl palmitate can be theantioxidant in the formulations listed in Table I. Antioxidants can beincorporated into the polymer (e.g., polyurethane) during the extrusionprocess.

A variety of synthetic and/or natural sweeteners can be in theextrudate. Suitable natural sweeteners include sugars, for example,monosaccharides, disaccharides, and/or polysaccharide sugars, and/ormixtures of two or more sugars. According to some embodiments, theextrudate includes one or more of the following: sucrose or table sugar;honey or a mixture of low molecular weight sugars not including sucrose;glucose or grape sugar or corn sugar or dextrose; molasses; cornsweetener; corn syrup or glucose syrup; fructose or fruit sugar; lactoseor milk sugar; maltose or malt sugar or maltobiose; sorghum syrup;mannitol or manna sugar; sorbitol or d-sorbite or d-sorbitol; fruitjuice concentrate; and/or mixtures or blends of one or more of theseingredients. The extrudate can also include non-nutritive sweeteners.Suitable non-nutritive sweeteners include: stevia, saccharin; Aspartame;sucralose; or acesulfame potassium.

The extrudate can optionally include one or more flavorants. Theflavorants can be natural or artificial. For example, suitableflavorants include wintergreen, cherry and berry type flavorants,various liqueurs and liquors (such as Drambuie, bourbon, scotch, andwhiskey) spearmint, peppermint, lavender, cinnamon, cardamom, apiumgraveolents, clove, cascarilla, nutmeg, sandalwood, bergamot, geranium,honey essence, rose oil, vanilla, lemon oil, orange oil, Japanese mint,cassia, caraway, cognac, jasmine, chamomile, menthol, ylang ylang, sage,fennel, pimenta, ginger, anise, coriander, coffee, liquorish, and mintoils from a species of the genus Mentha, and encapsulated flavors. Mintoils useful in particular embodiments of the oral product 110 includespearmint and peppermint. Synthetic flavorants can also be used. In somecases, a combination of flavorants can be combined to imitate a tobaccoflavor. The particular combination of flavorants can be selected fromthe flavorants that are generally recognized as safe (“GRAS”) in aparticular country, such as the United States. Flavorants can also beincluded in the oral product as encapsulated flavorants.

In some cases, the flavorants in the extrudate are limited to less than20 weight percent in sum. In some cases, the flavorants in the extrudateare limited to be less than 10 weight percent in sum. For example,certain flavorants can be included in the extrudate in amounts of about1 weight percent to 5 weight percent.

The extrudate may optionally include other additives. For example, theseadditives can include non-nicotine alkaloids, dietary minerals,vitamins, dietary supplements, therapeutic agents, and fillers. Forexample, suitable vitamins include vitamins A, B1, B2, B6, C, D2, D3, E,F, K, and P. For example, an extrudate can include C-vitamins withnicotine. Suitable dietary minerals include calcium (as carbonate,citrate, etc.) or magnesium (as oxide, etc.), chromium (usually aspicolinate), and iron (as bis-glycinate). One or more dietary mineralscould be included in an extrudate with or without the use of otheradditives. Other dietary supplements and/or therapeutic agents can alsobe included as additives.

In some cases, an oral product can be made to include a therapeuticagent that is preferable absorbed transbuccally. For example, certaintherapeutic agents do not significantly pass into the blood stream ifthey are swallowed. Exemplary therapeutic agents that can be included inan extrudate provided herein can include Gerd, Buprenorphin,Nitroglycerin, Diclofenac, Fentanyl, Carbamazepine, Galantamine,Acyclovir, Polyamidoamine Nanoparticles, Chlorpheniramine, Testosterone,Estradiol, Progesterone, Calcitonin, Fluorouracil, Naltrexone,Odansetron, Decitabine, Selegiline, Lamotrigine, and Prochlorperazine.For example, an oral product can include Buprenorphine and be used forpain treatment. In some cases, an oral product can include Nitroglycerinand be used for Angina Pectoris treatment. Because of the releaseproperties of the oral product, therapeutic agents included therein canbe released at a rate such that a majority of the therapeutic agent isabsorbed transbuccally, rather than swallowed.

The extrudate can also include fillers such as starch, di-calciumphosphate, lactose, sorbitol, mannitol, and microcrystalline cellulose,calcium carbonate, dicalcium phosphate, calcium sulfate, clays, silica,glass particles, sodium lauryl sulfate (SLS), glyceryl palmitostearate,sodium benzoate, sodium stearyl fumarate, talc, and stearates (e.g., Mgor K), and waxes (e.g., glycerol monostearate, propylene glycolmonostearate, and acetylated monoglycerides), stabilizers (e.g.,ascorbic acid and monosterol citrate, BHT, or BHA), disintegratingagents (e.g., starch, sodium starch glycolate, cross caramellose, crosslinked PVP), pH stabilizers, or preservatives. In some cases, the amountof filler in the oral product 110 is limited to less than 10 weightpercent in sum. In some cases, the amount of filler in the extrudate islimited to be less than 5 weight percent in sum. In some cases, thefillers are mouth stable. In some cases, the fillers can dissolve ordisintegrate during use and thus result in an oral product that becomesmore pliable during use.

Fibers

The extrudate can include fibers within the mouth-stable polymer matrix.In some cases, the extrudate includes between 5 weight percent and 50weight percent fibers. When in the oral product, the fibers can providepassages in the mouth-stable polymer matrix, which can permit certainadditives within the polymer matrix to be released into an oral cavitywhen the oral product is received in an oral cavity and exposed tosaliva. The fibers can be cellulosic fibers. The cellulosic fibers canbe derived from plant tissue. In some cases, the cellulosic fibersinclude cellulose. The cellulosic fibers can further include ligninand/or lipids. Suitable sources for cellulosic fibers include wood pulp,cotton, sugar beets, bran, citrus pulp fiber, switch grass and othergrasses, Salix (willow), tea, and Populus (poplar). In some cases, thecellulosic fibers can be chopped or shredded plant tissue comprisingvarious natural flavors, sweeteners, or active ingredients. In somecases, the oral product 110 can include nicotine as an additive(optionally with additional sweeteners and flavors) and non-tobaccocellulosic fiber, and thus be substantially free of tobacco planttissue.

The cellulosic fibers can have a variety of dimensions. The dimensionsof the fibers (in addition to the amount) can impact the releasecharacteristics of the additives. For example, cellulosic fibers can behydrophilic, thus water soluble additives (e.g., nicotine) canpreferentially be absorbed in fiber-polymer matrix. The release profileof nicotine from a polyurethane oral product can be impacted by both thefiber sizes and the amounts of fiber. In some cases, the cellulosicfiber can be processed to have an average fiber size of less than 200micrometers. In particular embodiments, the fibers are between 75 and125 micrometers. In some cases, the fibers are processed to have a sizeof 75 micrometers or less.

The extrudate can also include soluble fibers. The soluble fibers can beadapted to dissolve when exposed to saliva when the oral product isreceived in an oral cavity. In some cases, the soluble fiber can be amaltodextrin. The maltodextrin can be derived from corn. For example,Soluble Dietary Fiber can be included in an extrudate. Soluble fiberscan be used alone or with cellulosic fibers to provide channels foradditives to be released from the oral product. As the soluble fibersdissolve, the oral product can become more flexible and the additionalchannels can open up to permit the release of additional additivedeposits. Suitable soluble fibers include psyllium fibers. In somecases, the fibers can be partially soluble. For example, sugar beetfibers can partially dissolve during use.

In some cases, an oral product 110 can include a combination of solubleand insoluble fibers. The ratio of soluble to insoluble fiber can impactthe softness of texture of the oral product. The ratio of soluble toinsoluble fiber can also impact the compressibility of the oral product.In some cases, a ratio of soluble to insoluble fiber is between 1:60 and60:1. In some cases, the ratio of soluble to insoluble fiber is greaterthan 1:50, greater than 1:40, greater than 1:30, greater than 1:20,greater than 1:10, or greater than 1:5. In some cases, the ratio ofsoluble to insoluble fiber is less than 1:1, less than 1:2, less than1:5, less than 1:10, less than 1:20, or less that 1:30. In some case, anoral product having a mixture of soluble and insoluble fibers can have apercentage of compression @ 250 N of between 60 percent and 98 percent,between 65 percent and 95 percent, between 70 percent and 90 percent, orbetween 80 and 89 percent.

Plasticizers

The extrudate can also include one or more plasticizers. Plasticizerscan soften the final oral product and thus increase its flexibility.Plasticizers work by embedding themselves between the chains ofpolymers, spacing them apart (increasing the “free volume”), and thussignificantly lowering the glass transition temperature for the plasticand making it softer. Suitable plasticizers include propylene glycol,glycerin, vegetable oil, and medium chain triglycerides. In some cases,the plasticizer can include phthalates. Esters of polycarboxylic acidswith linear or branched aliphatic alcohols of moderate chain length canalso be used as plasticizers. Moreover, plasticizers can facilitate theextrusion processes described below. In some cases, the extrudate caninclude up to 20 weight percent plasticizer. In some cases, theextrudate includes between 0.5 and 10 weight percent plasticizer, theextrudate can include between 1 and 8 weight percent plasticizer, orbetween 2 and 4 weight percent plasticizer. For example, an oral productcomprising a polyurethane polymer matrix and include about 3 to 6.5weight percent of propylene glycol.

Other Embodiments

It is to be understood that, while the invention has been describedherein in conjunction with a number of different aspects, the foregoingdescription of the various aspects is intended to illustrate and notlimit the scope of the invention, which is defined by the scope of theappended claims. Other aspects, advantages, and modifications are withinthe scope of the following claims.

Disclosed are methods and compositions that can be used for, can be usedin conjunction with, can be used in preparation for, or are products ofthe disclosed methods and compositions. These and other materials aredisclosed herein, and it is understood that combinations, subsets,interactions, groups, etc. of these methods and compositions aredisclosed. That is, while specific reference to each various individualand collective combinations and permutations of these compositions andmethods may not be explicitly disclosed, each is specificallycontemplated and described herein. For example, if a particularcomposition of matter or a particular method is disclosed and discussedand a number of compositions or methods are discussed, each and everycombination and permutation of the compositions and the methods arespecifically contemplated unless specifically indicated to the contrary.Likewise, any subset or combination of these is also specificallycontemplated and disclosed.

What is claimed is:
 1. A machine for forming a plurality of oralproducts comprising: a. an extruder having an extruder die, theextrusion die having a predetermined cross-sectional shape; b. a seriesof pairs of forming rollers positioned to receive an extrudate from theextrusion die, each pair of forming rollers abutting each other anddefining a passage there between as each forming roller rotates, eachpassage having a cross-sectional shape corresponding to thepredetermined cross-sectional shape; and c. a cutting device positionedto receive and cut an extrudate from the series of pairs of formingrollers.
 2. The machine of claim 1, further comprising a plurality ofholding rollers positioned between the extrusion die and the series ofpairs of forming rollers.
 3. The machine of claim 1, wherein eachpassage of each pair of forming rollers has the same cross-sectionalshape and dimensions.
 4. The machine of claim 1, further comprising adrive motor and a gear train adapted to rotate each pair of formingrollers at the same outer linear speed.
 5. The machine of claim 1,wherein the extrusion die has the same cross-section shape anddimensions as the passage of a first pair of forming rollers.
 6. Themachine of claim 1, wherein the cutting device includes a cutting ledgeradapted to support an extrudate as it is cut.
 7. The machine of claim 6,wherein the cutting ledger comprises a plurality of channels therethrough adapted to receive a heat-exchange fluid.
 8. The machine ofclaim 1, wherein the cutting device comprises a rotary cutting blade. 9.The machine of claim 1, further comprising a sensor adapted to detect aleading edge of an extrudate and to actuate the cutting device.
 10. Themachine of claim 1, further comprising a programmable logic controlleradapted to control an extrusion rate, a speed of rotation of the formingrollers, and a timing of the cutting device.